The following data is part of a premarket notification filed by Vanguard Biomedical Corp. with the FDA for Miniclinic Ovulation Predictor.
| Device ID | K960233 |
| 510k Number | K960233 |
| Device Name: | MINICLINIC OVULATION PREDICTOR |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | VANGUARD BIOMEDICAL CORP. 10225 BARNES CANYON RD., SUITE A-108 San Diego, CA 92121 |
| Contact | John Chjiu |
| Correspondent | John Chjiu VANGUARD BIOMEDICAL CORP. 10225 BARNES CANYON RD., SUITE A-108 San Diego, CA 92121 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-17 |
| Decision Date | 1996-04-23 |
| Summary: | summary |